Spasticity, MuscleNCT03910101
Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment
A study testing Hand surgery and intensive rehabilitation in people with Spasticity, Muscle and Spinal Cord Injuries, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Spasticity - a variety of motor over-activity and part of the upper motor neuron syndrome - is a common cause of impaired motor function after brain injuries of different etiologies. In addition, it may cause pain and impaired hygiene, contractures, deformities etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Muscle, Spinal Cord Injuries, Traumatic Brain Injury
- What is being tested?
- Hand surgery and intensive rehabilitation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jan 2019to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities
Mölndal, Västra Götaland County, 431 30
About this study
Spasticity - a variety of motor over-activity and part of the upper motor neuron syndrome - is a common cause of impaired motor function after brain injuries of different etiologies. In addition, it may cause pain and impaired hygiene, contractures, deformities etc. Spasticity has been reported in 30 to 90% of patients with stroke, traumatic brain injury (TBI), incomplete spinal cord injury (SCI) and cerebral palsy (CP).
Spasticity therapy has emerged as an important approach to alleviate related symptoms. Positive effects on spasticity are well recognized following systemic and intra-thecal pharmacological treatment, as well as after intra-muscularly injected substances; the effect of the latter is, however, of limited duration. While pharmacological spasticity therapy has been applied for decades, surgical procedures remain fairly uncommon in adults with spasticity, but not in pediatric patients with CP, and outcomes after surgical treatment are scarcely described in the literature.
The study center is a specialized unit initially focused on reconstructive as well as spasticity reducing surgery in the upper extremities for SCI patients. Subsequently, patients with spasticity also due to various other Central nervous system diseases have been referred to the center for surgical treatment. Studies describing the effect of spasticity-reducing surgery in the upper extremities are rare and the group is heterogeneous. The aim of the study is evaluating the long-term efficacy of spasticity-correcting surgery versus BoNT in patients with disabling UL spasticity. As a secondary aim, we want to compare the peak effects of the two treatments, Botulinum toxin injections and spasticity-correcting surgery.
Read the detailed description
Study design and participants This study used a pretest-posttest quasi-experimental design.
Study participants are recruited using two parallel procedures. I) Review of a hospital-based register of patients who had been treated or referred to the tonus clinic identified eligible patients, who were then sent information about the study, along with their contact information to the researcher responsible for the study. II) Patients with ongoing BoNT treatment who had been referred to the Center for Advanced Reconstruction of Extremities (C.A.R.E.), and were eligible for the present study were informed about the study and enrolment procedure.
All presumptive study participants will undergo a screening procedure by the primary examiner, to assess whether they met the study's eligibility criteria. Written informed consent will be obtained if the patient met the inclusion criteria and consented to participate. All patients are offered either of the two treatment methods, the treatment allocation are based on individual preferences. The study will be conducted in accordance with relevant ethical guidelines (Declaration of Helsinki).
The primary outcome measure are muscle tone, measured using the Modified Ashworth Scale (MAS). The single-item MAS was measured on a six-point scale from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with an additional point allocated at 1+ (slight increase in muscle tone). As such, the MAS provides a single score to represent spasticity in a specific movement. For analysis, the MAS scores of the treated muscles were summed to obtain a "composite spasticity score" for each participant.
Secondary outcomes includes measures within, body function, activity and Participation.
The calculation of sample size was based on the a priori defined difference to be detected, with an alpha level of 5% and a power goal of 80%, as well as the primary outcome variable MAS and previous findings. Provide a number of 14 participants in each of the two groups. We expected a dropout rate of 15%, and therefore aimed to include 17 individuals in each group to achieve 80% power.
Between-group differences and within-group differences in treatment efficacy will be analysed by comparing pretest-posttest changes.
- Conditions
- Spasticity, Muscle, Spinal Cord Injuries, Traumatic Brain Injury, Stroke, Upper Extremity Paresis
- Being tested
- Hand surgery and intensive rehabilitation
- Medical subject headings
- Muscle Spasticity, Spinal Cord Injuries, Brain Injuries, Traumatic, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand surgery and intensive rehabilitationProcedure or surgery
Also called Botulinum toxin injections and rehabilitation
Spasticity-correcting upper-limb surgery comprised lengthening of tendons, release of muscles, and occasionally correction of deformities. Rehabilitation starts the first post-operative day and comprised physiotherapy and occupational therapy. Patients are also taught a home-training program. Up to 1 week of intensive in-hospital rehabilitation followed 3 weeks after surgery and a new home-training program are designed.
| Study group | Role | What they receive |
|---|---|---|
| Hand surgery and intensive rehabilitation | Active comparator | The surgical treatment for reducing spasticity comprises lengthening of tendons, muscle release and occasionally correction of deformities. Lengthening of a tendon or releasing a muscle from its insertion, results in relaxation of the whole muscle-tendon unit. Hence, the spasticity is not gone, but reduced in strength.
The tendon lengthening procedures is performed by a stair-step incision technique followed by reattachment in the lengthened position using a side-to-side, cross-stich technique. The load to failure of the sutured tendon is approximately 200Newton, which gives a sufficient safety margin for early active mobilization of the tendons involved. This suture technique thus enables active training directly after surgery.
Postoperative rehabilitation includes wrapping and a custom-made splint, for day and night use, muscle activation and passive stretching 2-4 times per day without the splint. Receives: Procedure: Hand surgery and intensive rehabilitation |
| Botulinum toxin injections | Active comparator | Botulinum toxin injections are given in spastic muscles of the upper extremity. Dosage and number of injections per muscle vary depending on the degree and extent of spasticity. For optimal effect on hand function, botulinum toxin is accompanied by the treatment of individualized exercise and splinting when needed. Receives: Procedure: Hand surgery and intensive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is being assessed with Modified Ashworth Scale
0-5 scale that quantify the degree of resistance to passive movement of the target muscle group
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Secondary outcomes (10)
Change is being assessed with Visual Analog scale (VAS)
for pain, patient's self-rating of general arm-hand function (usefulness), appearance of the hand and self-rating spasticity. Visual Analog Scale is a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured. Orientated from the left no; pain, spasticity, problem with appearance to the right worst possible; pain, spasticity, problem with appearance. In the general hand function question the scale goes from left side no hand function to the right side best possible hand function. In the pain, spasticity and appearance question a high number indicate a worse outcome, in the general hand function question a high number represent a better outcome. Respondents specify their level of agreement to the statement by indicating a position along the line.
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with goniometry
to measure joint resting position and passive and active range of motion (ROM). Higher numbers indicates better outcomes
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Jamar dynamometer
grip strength, higher scores indicates better outcomes
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with pinch gauge
measuring strength in the two- point tip- and lateral key-pinch, Higher scores indicates better outcomes
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with opening of the hand passive, Active and resting position
Five step scale that goes from closed, 1/4 opened, 1/2 opened, 3/4 opened, open hand. Higher scores indicates better outcomes.
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with The Canadian Occupational Performance Measure (COPM)
measuring performance and satisfaction of therapy regarding the most important activity limitations due to spasticity (up to 5) as chosen and assessed by the patient on a scale from 1-10, higher number indicates better outcomes.
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Grasp and Release Test (GRT)
assessing the patients' ability to grasp, move, and release 6 objects of varying weight and size during 30 seconds. Higher scores indicates better outcomes.
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Arm Activity Measure (ArmA)
a patient reported outcome measure of active and passive function in the hemiparetic upper limb. Lower scores indicates better outcomes.
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Cylinder test
the test is measuring the opening and grasp ability of the patient's hand. The test evaluate four different way of grasping; normal one hand grip, adapted one hand grip, two hand grip and adapted two hand grip. The test consists cylinders in 15 different sizes from 10mm to 150mm. The cylinder test enables measuring progress of opening the hand during rehabilitation or before and after surgery. Higher scores indicates better outcomes.
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Functional score
Grade the upper limb function (1-4). Description
- Absence of useful active mobility and uneasy and painful passive mobilization, making difficult to dress and wash
- Easy passive mobilization but without any useful voluntary movements
- Slight but useful voluntary motor function
- Good active mobility with the possibility of prehension in the hand and fingers. Higher numbers indicates better outcomes
Measured: Change from baseline and at the the time points 4-6weeks and 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start25 Jan 2019
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lina Bunketorp Kall, PhD, Study chair, University of Gothenburg, Sahlgrenska academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910101
- Sponsor's protocol ID
- Theno1RCT
- Status last verified
- Nov 2024
- First submitted
- 6 Mar 2019
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment
- ClinicalTrials.gov ID
- NCT03910101
- Acronym / sponsor ID
- Theno1RCT
- Conditions
- Spasticity, Muscle, Spinal Cord Injuries, Traumatic Brain Injury, Stroke, Upper Extremity Paresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spasticity - a variety of motor over-activity and part of the upper motor neuron syndrome - is a common cause of impaired motor function after brain injuries of different etiologies. In addition, it may cause pain and impaired hygiene, contractures, deformities etc. Spasticity has been reported in 30 to 90% of patients with stroke, traumatic brain injury (TBI), incomplete spinal cord injury (SCI) and cerebral palsy (CP).
Spasticity therapy has emerged as an important approach to alleviate related symptoms. Positive effects on spasticity are well recognized following systemic and intra-thecal pharmacological treatment, as well as after intra-muscularly injected substances; the effect of the latter is, however, of limited duration. While pharmacological spasticity therapy has been applied for decades, surgical procedures remain fairly uncommon in adults with spasticity, but not in pediatric patients with CP, and outcomes after surgical treatment are scarcely described in the literature.
The study center is a specialized unit initially focused on reconstructive as well as spasticity reducing surgery in the upper extremities for SCI patients. Subsequently, patients with spasticity also due to various other Central nervous system diseases have been referred to the center for surgical treatment. Studies describing the effect of spasticity-reducing surgery in the upper extremities are rare and the group is heterogeneous. The aim of the study is evaluating the long-term efficacy of spasticity-correcting surgery versus BoNT in patients with disabling UL spasticity. As a secondary aim, we want to compare the peak effects of the two treatments, Botulinum toxin injections and spasticity-correcting surgery.
Detailed description
Study design and participants This study used a pretest-posttest quasi-experimental design.
Study participants are recruited using two parallel procedures. I) Review of a hospital-based register of patients who had been treated or referred to the tonus clinic identified eligible patients, who were then sent information about the study, along with their contact information to the researcher responsible for the study. II) Patients with ongoing BoNT treatment who had been referred to the Center for Advanced Reconstruction of Extremities (C.A.R.E.), and were eligible for the present study were informed about the study and enrolment procedure.
All presumptive study participants will undergo a screening procedure by the primary examiner, to assess whether they met the study's eligibility criteria. Written informed consent will be obtained if the patient met the inclusion criteria and consented to participate. All patients are offered either of the two treatment methods, the treatment allocation are based on individual preferences. The study will be conducted in accordance with relevant ethical guidelines (Declaration of Helsinki).
The primary outcome measure are muscle tone, measured using the Modified Ashworth Scale (MAS). The single-item MAS was measured on a six-point scale from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with an additional point allocated at 1+ (slight increase in muscle tone). As such, the MAS provides a single score to represent spasticity in a specific movement. For analysis, the MAS scores of the treated muscles were summed to obtain a "composite spasticity score" for each participant.
Secondary outcomes includes measures within, body function, activity and Participation.
The calculation of sample size was based on the a priori defined difference to be detected, with an alpha level of 5% and a power goal of 80%, as well as the primary outcome variable MAS and previous findings. Provide a number of 14 participants in each of the two groups. We expected a dropout rate of 15%, and therefore aimed to include 17 individuals in each group to achieve 80% power.
Between-group differences and within-group differences in treatment efficacy will be analysed by comparing pretest-posttest changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand surgery and intensive rehabilitation | Active comparator | Procedure: Hand surgery and intensive rehabilitationThe surgical treatment for reducing spasticity comprises lengthening of tendons, muscle release and occasionally correction of deformities. Lengthening of a tendon or releasing a muscle from its insertion, results in relaxation of the whole muscle-tendon unit. Hence, the spasticity is not gone, but reduced in strength. The tendon lengthening procedures is performed by a stair-step incision technique followed by reattachment in the lengthened position using a side-to-side, cross-stich technique. The load to failure of the sutured tendon is approximately 200Newton, which gives a sufficient safety margin for early active mobilization of the tendons involved. This suture technique thus enables active training directly after surgery. Postoperative rehabilitation includes wrapping and a custom-made splint, for day and night use, muscle activation and passive stretching 2-4 times per day without the splint. |
| Botulinum toxin injections | Active comparator | Procedure: Hand surgery and intensive rehabilitationBotulinum toxin injections are given in spastic muscles of the upper extremity. Dosage and number of injections per muscle vary depending on the degree and extent of spasticity. For optimal effect on hand function, botulinum toxin is accompanied by the treatment of individualized exercise and splinting when needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand surgery and intensive rehabilitationAlso: Botulinum toxin injections and rehabilitationSpasticity-correcting upper-limb surgery comprised lengthening of tendons, release of muscles, and occasionally correction of deformities. Rehabilitation starts the first post-operative day and comprised physiotherapy and occupational therapy. Patients are also taught a home-training program. Up to 1 week of intensive in-hospital rehabilitation followed 3 weeks after surgery and a new home-training program are designed. | Procedure or surgery | Botulinum toxin injections, Hand surgery and intensive rehabilitation |
Primary outcome
Change is being assessed with Modified Ashworth Scale
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
0-5 scale that quantify the degree of resistance to passive movement of the target muscle group
10 secondary outcomes
Change is being assessed with Visual Analog scale (VAS)
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with goniometry
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Jamar dynamometer
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with pinch gauge
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with opening of the hand passive, Active and resting position
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with The Canadian Occupational Performance Measure (COPM)
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Grasp and Release Test (GRT)
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Arm Activity Measure (ArmA)
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Cylinder test
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Change is being assessed with Functional score
Time frame: Change from baseline and at the the time points 4-6weeks and 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Spasticity, Muscle
Active, not recruiting
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Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lina Bunketorp Kall, PhD study chair
University of Gothenburg, Sahlgrenska academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand surgery and intensive rehabilitation in people with Spasticity, Muscle and Spinal Cord Injuries, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is being assessed with Modified Ashworth Scale (time frame: Change from baseline and at the the time points 4-6weeks and 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.